BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL/XLAT POR PROFILE 13MM

    MDR report key: 7805421 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-08133
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    September 19, 2017
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# RD118856, M2A 38MMX56MM CUP, LOT# 637570; ITEM# 11-173665, M2A 38MM MOD HD+9MM NK NO SKRT, LOT# 179150; ITEM# 113846, TITANIUM SCREW LOW PROF 5X30MM, LOT# 281211. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08134; 0001825034 - 2018 - 08132.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY APPROXIMATELY 15 YEARS AGO. PATIENT UNDERWENT REVISION 14 YEARS POST IMPLANTATION FOR UNKNOWN REASON. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647771 INTEGRAL/XLAT POR PROFILE 13MM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 567210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R